Formulation comprising GLP-1

• US 8,492,330 B2
• Filed: 01/12/2011
• Issued: 07/23/2013
• Est. Priority Date: 02/20/2002
• Status: Expired due to Term

• Current Assignee: NOVO Nordisk North America Operations A/S (Novo Nordisk A/S)
• Original Assignee: Emisphere Technologies, Inc. (Novo Nordisk A/S)
• Inventors: Khan, Mohammed Amin, Jones, Bryan Edward, McGill, John McNeill
• Primary Examiner(s): PAK, MICHAEL D
• Application Number:
  US13/004,964
• Publication Number:
  US 20110178006A1
• Time in Patent Office: 923 Days
• Field of Search: None
• US Class Current: 514/1.1
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 47/18 Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/48 of the pancreatic hormones
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

The invention relates to formulations that demonstrate the feasibility of oral absorption comprising glucose-like peptide-1 compounds and specified delivery agents, and to methods of stimulating GLP-1 receptor in a subject in need of such stimulation, by administration of the formulation of the present invention.

Claims

1. A formulation comprising a GLP-1 compound of SEQ ID NO:

2 and a delivery agent of the formula

2. The formulation of claim 1, wherein the GLP-1 compound is DPP IV resistant.

3. The formulation of claim 1, wherein the delivery agent is a sodium salt of

4. An oral pharmaceutical composition comprising:

(i) a GLP-1 compound, wherein the GLP-1 compound is a GLP-1 derivative comprising a polypeptide of SEQ ID NO;

2; and

(ii) a delivery agent selected from

5. The oral pharmaceutical composition of claim 4, wherein the delivery agent is a sodium salt of